Connected Care for Type 2 Diabetes Self-Management
ConditionDiabetes Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarche Region Regional Health Agency
About this trial
The primary objective of this Randomized Clinical Trial is to improve the self-management (SM) competencies of patients affected by Type 2 Diabetes Mellitus (T2DM) living in the Marche region (Italy) through the support of a mobile health (m-health) solution personalised by the diabetologist and integrated with the Electronic Patient Record (EPR), assessed through the change in glycated haemoglobin (HbA1c) levels (%) from baseline to the end of the intervention (primary outcome).
Researchers will compare the use of the m-health solution (treated group) to usual T2DM care (control group) in determining change in HbA1c levels (%). The intervention will start at the Diabetic Centres (CADs) where patients are currently followed up and will then take place in each participant's home
Participants of the treated group will:
* receive dedicated training on the use of the m-health solution * receive the personalization of the m-health solution * use the m-health solution to: 1) track and view the data related to their health status (e.g., glycaemic status, lifestyle habits, diet) and treatment plane; 2) receive alerts and motivational messages; communicate with the Health Care Professionals (HCPs) of the Diabetic Centre (CAD) in case of need; 3) access to the educational material and to the technical assistance, when needed.
HCPs will be able to monitor the patients' data and clinical parameters and to communicate with the patients. After a baseline evaluation (T0), three follow-up evaluations will be conducted at 4, 8 and 12 months (T1-T2-T3 respectively) , during the usual physician' visits, as part of clinical routine.
The evaluation phases (T0, T1, T2, T3) will be conducted through data derived from: 1) self-administered and paper-based questionnaires, validated in the Italian language; 2) the clinical assessment of patients; 3) the m-health solution, as data automatically derived from the m-health solution; 4) a focus group carried out in a subsample of participants.
Data regarding different health-related areas (T2DM severity; medication adherence; lifestyle habits; self-efficacy related to management of the disease; quality of life), usability of the m-health solution, participants' experience with the intervention, utilization of the m-health solution by the patients, and the cost-effectiveness of the intervention, will be evaluated.
Patients participating in the study will not be required to make any additional visits or undergo any laboratory analysis beyond those specified in their therapeutic plan.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with T2DM (as confirmed by the physician's diagnosis);
belonging to one of the 13 Diabetes Centres (CADs) of the Marche region in Italy (Pesaro, Urbino, Fano, Senigallia, Jesi, Fabriano, IRCCS-INRCA, Azienda Ospedaliera Universitaria delle Marche, Civitanova Marche, Macerata, Fermo, San Benedetto del Tronto e Ascoli Piceno);
age > = 18;
resident in the Marche region;
Disqualifiers
acute medical problems: myocardial infarction or stroke within 6 months, difficulty in exercise and physical activity due to spinal disease (intervertebral disc prolapse, spinal stenosis, etc.), joint disease, or major surgery at the time of screening, painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility, advanced Parkinson's disease and/or neuromuscular disorders, advanced dementia, metastatic cancer, in long-term immunosuppressant therapy, significant visual or hearing impairment, uncontrolled hypertension or other serious conditions that restrict their participation in the study, severe/major depression and other relevant psychiatric disorders;
estimated glomerular filtration rate < 30 mL/min/1.73 m2;
plan to receive surgery that could limit physical activity during the study period;
pregnant or breastfeeding;
Trial design
Design model
Parallel
Treatments tested in this trial
M-health solution classified as Class I Medical Devices, equipped with a CE certificate. The m-health solution will be integrated with the EPR currently used by the CADs of the Marche region
DeviceThe m-health solution used in the study includes the following interfaces: 1. for the HCPs of the CADs: * a section of the EPR currently used (Metaclinic), to set the mobile application and to collect clinical data recorded by the patients; * a software to develop and monitor personalised diets (MetaDieta); 2. for the patients: two mobile applications, one for the monitoring of the clinical data and life style (DiaWatch Meteda) and one for the monitoring of the diet (MyDiet), with the latter accessible from a 'button' included in the first one. The HCPs of the CADs, already having access to the EPR Metaclinic, will access a dedicated section for the setting of the target values and goals (e.g., glycaemia, physical activity, etc.) and for the activation of the app DiaWatch Meteda. After the connection of the app with Metaclinic, the data registered in the apps by the patients will be visible by the HCPs in the EPR dashboard.
Treatment groups
388 Participants
are divided into 2 treatment groupsGroup A: Treated group (utilizing m-health solution)Active comparator 1 intervention
Group B: Control group (attending usual T2DM care)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
To improve the SM competencies of patients affected by T2DM living in the Marche region through the support of a m-health solution personalized by the diabetologist and integrated with the EPR of patients.
This outcome will be assessed through the change in HbA1c levels (%)
Time frame
This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 4, at month 8 and at month 12.Secondary outcomes
1
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed evaluating the change in the level of fasting glucose (mg/dl)
Time frame
This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 4, at month 8 and at month 12.2
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed evaluating the change in glycaemic variability/capillary blood glucose monitoring, when foreseen by patients' therapeutic plan
Time frame
This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 4, at month 8 and at month 12.3
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed evaluating the change in the levels of Serum total cholesterol (mg/dl), triglycerides (mg/dl), High-Density Lipoproteins (mg/dl) and Low-Density Lipoproteins cholesterol (mg/dl).
Time frame
This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 4, at month 8 and at month 12.4
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed evaluating the change in Microalbuminuria levels (mg/dl).
Time frame
This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 4, at month 8, and at month 12.Sponsors and contacts
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Source ClinicalTrials.gov